A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06276933 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: MA-NSCLC-II-039
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients

Conditions

Lung Cancer; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)

  Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)

  2 years

Secondary Outcomes (7)

• Median time to RCCEP

  2 years

• Median time to RCCEP of level 3 or above

  2 years

• Incidence rate of ≥G3 grade RCCEP

  2 years

• Overall Response Rate (ORR)

  2 years

• Progression-Free Survival (PFS)

  2 years

Study Arms (2)

Camrelizumab+Chemotherapy+Thalidomide

EXPERIMENTAL

Drug: Camrelizumab + chemotherapy+Thalidomide

Camrelizumab + chemotherapy+placebo

ACTIVE COMPARATOR

Drug: Camrelizumab + chemotherapy+placebo

Interventions

Camrelizumab + chemotherapy+Thalidomide DRUG

Camrelizumab + chemotherapy+Thalidomide Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: Thalidomide Thalidomide 100mg，po qd； Other Name: Thalidomide Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy

Camrelizumab+Chemotherapy+Thalidomide

Camrelizumab + chemotherapy+placebo DRUG

Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: placebo 100mg placebo 100mg，po qd； Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy

Camrelizumab + chemotherapy+placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, both male and female.
• Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung cancer.
• No prior systemic treatment to advanced NSCLC . Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 12 months from randomization since the last chemotherapy cycle.
• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Have a life expectancy of at least 3 months.
• All baseline laboratory requirements will be assessed.
• Can swallow pills normally.

You may not qualify if:

• Female Subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose, are not breastfeeding, and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. Male subjects whose partners are fertile women should be surgically sterilized or agree to use effective contraception during the trial period and 90 days after the last administration of the study drug, and sperm donation is not allowed during the study period.
• Subjects has voluntarily agreed to participate by giving written informed consent. Willing and able to follow planned visits, research treatments, laboratory tests and other test procedures.
• Patients with non-small cell lung cancer diagnosed with other histopathological types, including patients with NSCLC containing small cell lung cancer components.
• Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
• Patients who have previously received PD-(L)1 or CTLA-4 treatment.
• Subjects with active CNS metastases are excluded.
• Subjects with active, known or suspected autoimmune disease. Participants who are in a stable state and do not require systemic immunosuppressive therapy are permitted to enroll.
• Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection.
• Have the following poorly controlled infectious diseases: active viral hepatitis B or C; Have active TB or are currently receiving anti-TB treatment.
• There is past or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, vasculitis obliterans), drug-induced pneumonia, active pneumonia on CT examination, or severe impairment of lung function.
• Subjects with clinically significant cardiovascular and cerebrovascular diseases.
• Active infection (CTCAE\> Grade 2).
• Diagnosed with immune deficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor treatment within 7 days prior to study enrollment; Physiological doses of glucocorticoids are permitted.
• Other malignancies developed within 5 years prior to admission, excluding adequately treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
• Subjects received major surgery within 4 weeks of the first dose of study treatment or planned during the study period.

Sponsors & Collaborators

• Tongji University: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anwen Xiong, MD

  Department of Oncology, Shanghai pulmonary hospital Shanghai, China, 200433

  STUDY DIRECTOR

Central Study Contacts

Anwen Xiong, MD

CONTACT

18221013620; anwenxiong@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: February 22, 2024
• Primary Completion: November 22, 2025
• Study Completion (Estimated): November 22, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share